FDA.reportPublic FDA data

Hawaiian Natural Zinc Sunscreen SPF 50

Manufacturer
Kokua Sun Care | Columbia Cosmetics Manufacturing, Inc.
Effective date
2025-12-29
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:29:15

Label at a glance#

ProductHawaiian Natural Zinc Sunscreen SPF 50
Active ingredientZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Zinc Oxide 25% Sunscreen

OTC - PURPOSE SECTION

Uses

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), Decreases the risk of skin cancer and early skin aging caused by the sun.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If product is swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs

WARNINGS SECTION

Warnings:

  • For external use only
  • Do not use or broken skin
  • When using this product keep out of eyes

DOSAGE & ADMINISTRATION SECTION

Directions

  • Apply generously 15 minutes before sun exposure
  • Reapply:
  • After 80 minutes if swimming or sweating
  • Immediately after towel drying
  • At least every 2 hours
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 am-2pm.
  • Wear long-sleeve shirts, pants, hats, and sunglasses.
  • Children under 6 months: ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water (Aqua), Aloe Barbadensis Leaf Juice, Caprylyl Caprylate/Caprate, Polyglyceryl-2 Oleate, Macadamia Ternifolia Seed (Macadamia) Oil, Aleurites Moluccana Seed (Kukui) Oil, Polyhydroxystearic Acid, Cocos Nucifera (Coconut) Oil, Cetyl Dimethicone, Glyceryl Stearate, Glycerin, Hydrogenated Methyl Abietate, Magnesium Sulfate, Galactoarabinan, Propanediol, Polyglyceryl-2 Stearate, Morinda Citrifolia (Noni) Fruit Juice, Arthrospira Platensis (Hawaiian Spirulina), Oryza Sativa (Rice) Bran Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Helianthus Annuus (Sunflower) Seed Extract, Caprylic/Capric Triglyceride, Vanilla Planifolia Fruit Extract, Cocos Nucifera (Coconut) Fruit Extract, Tocopheryl Acetate, Plumeria Alba Flower Extract, Kaolin, Hydrogenated Vegetable Oil, 1,2-Hexanediol, Caprylhydroxamic Acid.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hawaiian Natural Zinc Sunscreen

Broad Spectrum SPF 50

Water Resistant 80 minutes

89 mL / 3 FL OZ

Tube LabelTube Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130861957000013GTIN-13: 0861957000013
EAN-13: 0861957000013
GTIN-12: 861957000013
UPC-A: 861957000013
GTIN storage (14 digits): 00861957000013		Artwork Kokua Untinted SPF 50 2025 Large.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72096-101-012025-12-30C16284748780-12cef2736-8434-d83d-e063-dadaa90ab31fKokua Hawaiian Natural Zinc Sunscreen SPF 50 (89 ml / 3 fl oz) (30 ml / 1 fl oz)
72096-101-022025-12-30C16284748780-12cef2736-8434-d83d-e063-dadaa90ab31fKokua Hawaiian Natural Zinc Sunscreen SPF 50 (89 ml / 3 fl oz) (30 ml / 1 fl oz)
72096-101-012025-01-30C16284748780-12cef2736-8434-d83d-e063-dadaa90ab31fKokua Hawaiian Natural Zinc Sunscreen SPF 50 (89 ml / 3 fl oz) (30 ml / 1 fl oz)
72096-101-022025-01-30C16284748780-12cef2736-8434-d83d-e063-dadaa90ab31fKokua Hawaiian Natural Zinc Sunscreen SPF 50 (89 ml / 3 fl oz) (30 ml / 1 fl oz)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72096-101-01Hawaiian Natural Zinc Sunscreen SPF 5089 g in 1 BOXLOTION895
72096-101-02Hawaiian Natural Zinc Sunscreen SPF 5030 g in 1 BOXLOTION305

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72096-10172096-101-01, 72096-101-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYGLYCERYL-2 OLEATE5759J47SAMIACT
GLYCERYL STEARATE230OU9XXE4IACT
POLYGLYCERYL-2 STEARATE253MC0P0YVIACT
NONI FRUIT JUICE6ULF85Z07JIACT
ARTHROSPIRA PLATENSIS9L3TIH1UUEIACT
RICE BRANR60QEP13ICIACT
ROSEMARYIJ67X351P9IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ZINC OXIDESOI2LOH54ZACTIB
KAOLIN24H4NWX5COIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
GALACTOARABINANSL4SX1O487IACT
MACADAMIA OIL515610SU8CIACT
COCONUT OILQ9L0O73W7LIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALOE VERA LEAF JUICERUE8E6T4NBIACT
KUKUI NUT OILTP11QR7B8RIACT
PLUMERIA ALBA FLOWERLGC8P2PC4HIACT
CETYL DIMETHICONE 25U4AS1BW4ZBIACT
MAGNESIUM SULFATEDE08037SABIACT
COCONUT3RT3536DHYIACT
SUNFLOWER OIL3W1JG795YIIACT
VANILLA PLANIFOLIA FRUITQ74T35078HIACT
CAPRYLYL CAPRYLATE/CAPRATE22MCG4RSMRIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
HYDROGENATED METHYL ABIETATEA23O709X8OIACT
PROPANEDIOL5965N8W85TIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hawaiian Natural Zinc Sunscreen SPF 50ZINC OXIDEKokua Sun Care64a5589b-735d-38ba-e053-2a91aa0ad8f42025-12-29WarningsExact identifier
ndc (package): 72096-101-01
ndc (package): 72096-101-02
ndc (product): 72096-101
ndc11 (package): 72096010101
ndc11 (package): 72096010102
spl id: 46b63682-0910-142e-e063-6394a90a403a
spl set id: 64a5589b-735d-38ba-e053-2a91aa0ad8f4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.